ID

37191

Beschrijving

Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease Diagnosis; ODM derived from: https://clinicaltrials.gov/show/NCT01594411 This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.

Link

https://clinicaltrials.gov/show/NCT01594411

Trefwoorden

Versies (1)
  1. 07-07-19 07-07-19 -
Houder van rechten

CardioDx

Geüploaded op

7 juli 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Gene Expression Test for Coronary Artery Disease Diagnosis NCT01594411

Engels

Eligibility Criteria

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have stable chest pain, typical or atypical angina or anginal equivalent?
Beschrijving

Chest Pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C1998435
UMLS CUI [3]
C0741026
UMLS CUI [4]
C0741034
Does the participant have signed the appropriate institutional review board approved informed consent form?
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2346499
UMLS CUI [1,2]
C0009797
UMLS CUI [1,3]
C1519316
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have a history of myocardial infarction?
Beschrijving

History of myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027051
Does the participant have a current myocardial infarction (mi) or acute coronary syndrome?
Beschrijving

Current myocardial damage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0027051
UMLS CUI [2]
C0948089
Does the participant have current new york heart association (nyha) class III or IV congestive heart failure symptoms?
Beschrijving

NYHA III-IV

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1536132
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1536133
Does the participant have any previous coronary revascularization?
Beschrijving

Previous coronary revascularization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0877341
Does the particpant have diabetes, suspected unstable angina, systemic infections or systemic inflammatory conditions?
Beschrijving

Interfering diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2,1]
C0332147
UMLS CUI [2,2]
C0002965
UMLS CUI [3,1]
C3714514
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0205373
UMLS CUI [4,2]
C0544805
Is the participant currently taking steroids, Immunosuppressive agents or chemotherapeutic agents?
Beschrijving

Interfering Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0038317
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0021081
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C0729502
Does the participant have any major surgery within 2 months?
Beschrijving

Major Surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C4018905
UMLS CUI [1,3]
C0040223
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Similar models

Eligibility Criteria

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Chest Pain
Item
Does the participant have stable chest pain, typical or atypical angina or anginal equivalent?
boolean
C0008031 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1998435 (UMLS CUI [2])
C0741026 (UMLS CUI [3])
C0741034 (UMLS CUI [4])
Informed Consent
Item
Does the participant have signed the appropriate institutional review board approved informed consent form?
boolean
C2346499 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
History of myocardial infarction
Item
Does the participant have a history of myocardial infarction?
boolean
C0262926 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Current myocardial damage
Item
Does the participant have a current myocardial infarction (mi) or acute coronary syndrome?
boolean
C0521116 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0948089 (UMLS CUI [2])
NYHA III-IV
Item
Does the participant have current new york heart association (nyha) class III or IV congestive heart failure symptoms?
boolean
C1457887 (UMLS CUI [1,1])
C1536132 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1536133 (UMLS CUI [2,2])
Previous coronary revascularization
Item
Does the participant have any previous coronary revascularization?
boolean
C0205156 (UMLS CUI [1,1])
C0877341 (UMLS CUI [1,2])
Interfering diseases
Item
Does the particpant have diabetes, suspected unstable angina, systemic infections or systemic inflammatory conditions?
boolean
C0011847 (UMLS CUI [1])
C0332147 (UMLS CUI [2,1])
C0002965 (UMLS CUI [2,2])
C3714514 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0205373 (UMLS CUI [4,1])
C0544805 (UMLS CUI [4,2])
Interfering Drugs
Item
Is the participant currently taking steroids, Immunosuppressive agents or chemotherapeutic agents?
boolean
C0521116 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0021081 (UMLS CUI [2,2])
C0521116 (UMLS CUI [3,1])
C0729502 (UMLS CUI [3,2])
Major Surgery
Item
Does the participant have any major surgery within 2 months?
boolean
C0679637 (UMLS CUI [1,1])
C4018905 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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